Cleared Traditional

K063395 - O&P BIVALVE CRANIAL MOLDING HELMET

K063395 is an FDA 510(k) clearance for O&P BIVALVE CRANIAL MOLDING HELMET, manufactured by Orthotic & Prosthetic Lab, Inc.. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K063395 · Orthotic & Prosthetic Lab, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
43d
Days
Class 2
Risk

K063395 is an FDA 510(k) clearance for the O&P BIVALVE CRANIAL MOLDING HELMET. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Orthotic & Prosthetic Lab, Inc. (Webster Groves, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063395

510(k) Number K063395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date December 22, 2006
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 149d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVA Device Classification - Class 2, Special Controls

Product Code MVA Orthosis, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MVA Orthosis, Cranial

All 42
Devices cleared under the same product code (MVA) and FDA review panel - the closest regulatory comparables to K063395.
MICHIGAN CRANIAL RESHAPING ORTHOSIS
K090341 · Danmar Products, Inc. · Jan 2010
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
K070694 · Mike Miner · Sep 2007
CRANIAL SOLUTION ORTHOSIS
K063133 · Cranial Solutions · Jul 2007
DOC BAND-POSTOP
K042385 · Cranial Technologies, Inc. · Dec 2004
CRANIAL HELMET
K041215 · Otto Bock Healthcare LP · Sep 2004
COPC BAND
K021594 · Center For Orthotic and Prosthetic Care,Llc · Nov 2003
K063395 · O&P BIVALVE CRANIAL MOLDING HELMET
Download PDF FDA Summary Orthotic & Prosthetic…